# Patent

## Title
Apparatus and method for simulated insertion and positioning of guidewares and other interventional devices

## Abstract

Apparatus and methods useable for simulated insertion and positioning of medical or surgical devices. The apparatus generally comprises a substantially flat structure having simulated body openings, anatomical passageways, anatomical structures and anatomical cavities formed therein. One or more windows (e.g., a transparent top panel or cover) allows the operator to observe the movement or positioning of the medical or surgical device.

## Background
FIELD OF THE INVENTION
The present invention relates generally to the fields of medicine and surgery and more particularly to devices and methods useable for training physicians and other personnel in the art of inserting and positioning guidewires, catheters, scopes and other medical or surgical devices.
BACKGROUND
A variety of medical and surgical procedures involve the insertion, navigation and placement of guidewires, catheters, scopes and other devices that are used to perform therapeutic or diagnostic procedures at intracorporeal treatment sites (e.g., e.g., within a vessel, cavity or passageway of the body). In many of these procedures, the guidewire, catheter, scope or other device must be carefully advanced through tortuous or branched body passages (e.g., nasal passages, blood vessels, gastrointestinal tract, biliary tree, urinary tract, etc.) and/or around existing anatomical structures, in order to reach an intended location. In some cases, the physician-in-training may be able to alter the shape of the device as it is advanced though the body passageways (e.g., as in the case of a steerable or deflectable guidewire, catheter, scope or other device). In other cases, the device may be of a substantially fixed configuration (e.g., straight or curved). In either event, the physician-in-training must learn techniques for pre-shaping (if necessary), advancing and navigating such devices through the available body passageways, around certain anatomical structures and to their intended intracorporeal locations.
In some cases, anatomical models have been used for training physicians or other health professionals in the insertion, navigation, positioning and/or use of guidewires, catheters, scopes or other devices. Such uses of anatomical models can sometimes enable physicians-in-training and other professions-in-training to gain initial experience in performing certain procedures or techniques in a relaxed, non-clinical setting before proceeding to more challenging work in cadavers, laboratory animals or actual human patients.
One particular anatomical model that has been used for training surgeons in the performance of endoscopic sinus surgery is the SurgTrainerTM Human Nasal Model for Endonasal Surgery Training available from SurgTrainer, Ltd., 4-4-21, Kasuga, Tsukuba City, Ibaraki 305-0821 Japan. Also see, see, Yamauchi Y, Yamashita J, Mochimaru M, Fukui Y, Niikura M, Uno H, Yokoyama K, “Development of a Silicone Model for Endoscopic Sinus Surgery,” proc CARS 99, p. 1039, 1999). This device generally includes a head-shaped housing into which various anatomical inserts may be interchangeably inserted and a soft plastic covering representing the skin and soft tissue structures of the patient's face. The interchangeable inserts represent various bone/sinus configurations representative of pathological conditions and, in at least some cases, are designed to be incised, drilled or cut by the surgeon undergoing training. This model is purported to be x-ray and CT compatible and may be used in conjunction with image guided surgical systems. However, devices such as the SurgTrainerTM Human Nasal Model for Endonasal Surgery Training may be less than optimal for training physicians in the performance of newer, less traumatic endonasal and sinus procedures. For example, new catheter-based procedures have been developed by Acclarent, Inc. of Menlo Park, Calif. for the performance of less traumatic Sinus and endonasal surgeries. These new procedures include, but are not limited to, uncinate-sparing procedures, uncinate-sparing ethmoidotmy procedures and implantation of drug delivery devices for treatment of paranasal sinusitis, using various catheters, instruments and advanced imaging techniques (Acclarent, Inc., Menlo Park, Calif.). Examples of these new devices, systems and methods are described in incorporated U.S. patent application Ser. Nos. 10/829,917 entitled Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat; 10/944,270 entitled Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures; 11/116,118 entitled Methods and Devices for Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses filed Apr. 26, 2005 and 11/150,847 filed Jun. 10, 2005, of which this application is a continuation-in-part. Catheter-based procedures are performed using various types of guidance including but not limited to C-arm fluoroscopy, transnasal endoscopy, intraoperative CT scan guidance, optical image guidance and/or electromagnetic image guidance.
Applicant has previously invented a device that may be used for simulated insertion and positioning of a working device (e.g., a balloon catheter) at a desired treatment site (e.g., within the ostium of a paranasal sinus). This device includes an indicator apparatus that provides an indication of when the working device has been used to cause some particular effect without causing substantial dismantling or destruction of the anatomical model. The indicator apparatus may indicate either a desired effect (e.g., the intended therapeutic or diagnostic effect of the working device) or an undesired effect (e.g., a complication, side effect, error, mistake or untoward effect) resulting from use of the working device. This device is described in co-pending U.S. patent application Ser. No. 11/527,773 entitled Anatomical Models and Methods for Training and Demonstration of Medical Procedures, the entire disclosure of which is expressly incorporated herein by reference.
There remains a need in the art for the development of additional devices and methods useable for training physicians and other health professionals in the insertion, navigation, placement and use of guidewires, catheters, scopes and other medical or surgical devices.
SUMMARY OF THE INVENTION
The present invention provides apparatus and methods useable for training physicians and other personnel in the art of inserting and positioning guidewires, catheters, scopes and other medical or surgical devices.
In accordance with one embodiment of the invention, there is provided an apparatus useable for simulated insertion and positioning of a medical or surgical device. This apparatus comprises a) a substantially flat first panel having a top surface, a bottom surface and at least one side surface; b) at least one simulated body opening (e.g., natural body opening, puncture site, incision, etc.) formed in a side surface of the first panel; c) at least one primary passageway extending inwardly from the simulated body opening; and d) a window through which an operator may view the medical or surgical device as it is inserted through the simulated body opening and advanced through at least the primary passageway. In some embodiments, the window may comprise a substantially transparent second panel attached (e.g., a clear plastic top panel) may be placed in substantial juxtaposition to the top or bottom surface of the first panel and a third panel (e.g., an opaque bottom panel) may be positioned in substantial juxtaposition to the other side of the first panel. One or more secondary passageway(s) may branch off of the primary passageway(s), one or more tertiary passageway(s) may branches off of the secondary passageway(s) and 1 or more additional passageways may branch off of any of the other passageway(s). Additionally, one or more simulated body cavities may be accessible through certain of the passageway(s). Simulated anatomical structures, such as anatomical processes or projections, organs, bones, etc., may be located adjacent to passageway(s) and/or body cavities. The passageway(s) may be straight, curved or tortuous and may mimic the anatomical configuration(s) (normal or anomalous) of actual body passages such as the nasal passages, nasal meatus, frontal tract, trachea, esophagus, duct, etc.). Similarly, the simulated body cavities may be shaped to correspond to the anatomical configuration(s) (normal or anomalous) of actual body cavities (e.g., paranasal sinuses).
Further in accordance with the invention, there is provided a method for using an apparatus of the above-summarized type, wherein an operator inserts one or more medical or surgical devices through one or more of the simulated body openings and advances such medical or surgical devices through one or more passageway(s). In some cases, the device(s) may be advanced into a simulated body cavity. The types of medical or surgical device(s) used may include, but are not limited to, catheters, guidewires, scopes and/or other working devices (e.g., dilation catheters, balloon catheters, atherectomy catheters, implantable devices, implantable substance delivery devices, etc.
Further aspects and details of the present invention will be understood upon reading of the detailed description and examples set forth herebelow.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of one embodiment of an apparatus of the present invention.
FIG. 2 is a top plan view of the apparatus of FIG. 1 having a guide and guidewire operatively inserted therein.
FIG. 2A is a side view of the apparatus of FIG. 1A.
FIG. 3 is an exploded view of the apparatus of FIG. 1.
FIG. 4A is a schematic diagram of an embodiment of an apparatus of the present invention incorporating an optional moveable member in a first position and having a guidewire, guide catheter and balloon catheter inserted therein.
FIG. 4B is a schematic diagram of the embodiment of FIG. 4B with the balloon inflated and the optional moveable member moved to a second position.
FIG. 5 is a schematic diagram of an embodiment of an apparatus of the present invention incorporating an optional opening in the second or top panel with an instrument inserted through such opening.



DETAILED DESCRIPTION
The following detailed description, the accompanying drawings are intended to describe some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description do not limit the scope of the invention in any way.
FIGS. 1-5 show several of many possible embodiments of the apparatus 10, 10a, 10b of the present invention. FIGS. 1-3 show an apparatus 10 which comprises a substantially flat first or middle panel 12, a substantially flat, transparent second or top panel 34 and a substantially flat, optionally opaque bottom panel 36. In an alternative embodiment, one or more of the panels can be combined in one panel. As seen specifically in the view of FIG. 2A, the first or middle panel 12 has a top T surface, a bottom surface B and side surfaces S. A plurality of simulated body openings 14 are formed in a side surface S of the first or middle panel 12. Primary passageways 16 extend inwardly from each simulated body opening 14. Secondary passageways 18 branch off of or are otherwise connected to the primary passageways 16. Tertiary passageways 20 branch off of or are otherwise connected to the secondary passageways 18. Additional passageways 24 may branch off of or may be otherwise connected (serially or in parallel) to the tertiary passageways 24. Simulated body cavities 26 may also be formed in the first or middle panel 12 and such body cavities 26 may be accessed through one or more of the passageways 16, 18, 20, 24.
The transparent second or top panel 34 serves as a window through which an operator may view medical or surgical device(s) as they are inserted through the simulated body openings 14 and advanced through the primary passageway 16. Positioning of medical or surgical devices often are done under fluoroscopic guidance during actual medical procedures. The transparent panel allows the operator to view the devices thus simulating fluoroscopic guidance. The third or bottom panel 36 may be a substantially flat panel attached in substantial juxtaposition to the bottom of the first or middle panel 12. The first (middle), second (top) and third (bottom) panels 12, 34, 36 may be stacked upon one another as shown and attached to one another by screws 40 or any other suitable attachment material or apparatus. Feet 38 may optionally be mounted or formed on the underside of the third or bottom panel 36 to facilitate placement of the apparatus 10 on a flat surface such as a desktop or laboratory bench.
Simulated anatomical structures 17 may be formed adjacent to the area formed in the panel adjacent to one or more of the passageways 16, 18, 20, 24 or cavities 26. In some embodiments, these simulated anatomical structures may be located and configured to represent anatomical processes or protrusions that the operator must avoid or navigate around. Also, in some embodiments, these anatomical structures 17 may represent sensitive or delicate anatomical structures that must not be penetrated or damaged as the operator advances a medical or surgical device through the passageways 16, 18, 20, 24 and/or into the cavities 26.
On the left side of this apparatus 10, the passageways 16, 18, 20, 24, cavities 26 and anatomical structures 17 are designed to simulate the paranasal anatomy so as to be useful for simulation of procedures wherein medical or surgical devices are inserted through the nose and used to perform endonasal or transnasal procedures including but not limited to procedures using Balloon SinuplastyTM tools as described in incorporated U.S. patent application Ser. No. 10/829,917, Ser. No. 10/944,270, Ser. No. 11/116,118 and Ser. No. 11/150,847 and/or the implantation of drug delivery devices, stents or other implants as described, for example, U.S. patent application Ser. No. 11/544,009, Ser. No. 11/234,395, Ser. No. 10/829,917, Ser. No. 10/912,578 and Ser. No. 10/470,881, which are also expressly incorporated herein by reference. In particular, the simulated body openings 14 include nasal openings NO of the nares. The passageways 16, 18, 20, 24, represent various endonasal passages, and the anatomical structures 17 simulate the nasal turbinates TR, septum SEP and uncinate process UP. The body cavities 26 represent a maxillary sinus MS, frontal sinus FS and orbits.
On the right side of this apparatus 10, a generic network of passageways 16, 18, 20, 24, body cavities 26 and anatomical structures 17 is provided. Thus generic network is not intended to simulate any specific portion of a patient's anatomy, but rather, includes various curves, protrusions, obstructions, narrowed areas and other attributes that are useful for general practice in advancing and positioning interventional devices such as guidewires, catheters, scopes, etc.
In typical use, the operator inserts a medical or surgical device through a simulated body opening 14 and then navigates such device(s) through passageways 16, 18, 20, 24, around anatomical structures 17 and in some cases into body cavities 26. The movement and/or positioning of such device(s) may be viewed continuously or at desired time points through the transparent second (top) panel 34. In the particular example shown in FIG. 1, a guide 30 has been inserted through the simulated body opening 14 that represents a nasal opening NO, advanced through a primary passageway 16 representing the nasal cavity NC and into a secondary passageway 18 representing the frontal recess FR.
The operator may observe such advancement and positioning of this guide 30 through the transparent second (upper) panel 34. Thereafter, a guidewire 32 is advanced through the guide 30 and into the adjacent body cavity 26 representing the frontal sinus FS. The operator may observe such advancement and positioning of the guidewire 32 through the transparent second (upper) panel 34.
As those of ordinary skill in the art will appreciate, once the guidewire 32 has been advanced into the simulated body cavity 26, another working device (not shown) may be advanced over the guidewire 32 and to a desired position, as the operator observes through the transparent second (upper) panel 34. Such working device may, in some cases, comprise a dilation catheter (e.g., a balloon catheter) that is advanced over the guidewire 32 to a position where its dilator (e.g., balloon) is positioned within a passageway representing the ostium of the frontal sinus FS. In some instances the guide 30 may be withdrawn and the working device may be advanced over the guidewire alone. In other instances, both the guide 30 and guidewire 32 may remain in place and the working device may be advanced through the guide 30 and over the guidewire 32. In still other applications, use of the guidewire GW may be unnecessary and a working device may simply be advanced through the guide 30. In addition to dilation catheters (e.g., balloon catheters) the types of working devices that may be inserted, advanced and positioned using this method include but are not limited to; cutting devices, atherectomy devices, implantable devices, implantable substance delivery devices, scopes, energy delivering devices, injection devices, sensors, electrodes, etc.
Because the panels 12, 34, 36 are substantially flat, the various passageways 16, 18, 20, 24, cavities 26 and anatomical structures 17 are substantially flat or two-dimensional while in an actual patient the body passages, structures and cavities represented thereby may exist in a more three dimensional state. By flattening or reducing the third dimension, this device 10 may allow an operator to initially learn to perform a particular procedure in two dimensions before progressing to a more anatomically accurate three-dimensional model or to work in an animal, cadaver or actual human patient.
FIGS. 4A and 4B show another apparatus 10a of the present invention that may be of the same basic construction as the embodiment shown in FIGS. 1-3, but which includes an optional moveable member 54 which may be used to indicate when a device, such as a balloon catheter 50 has been properly positioned and/or effectively used for an intended purpose. In the showing of FIG. 4A, the optional moveable member 54 is in a first position. A curved guide catheter 30a has been inserted into the apparatus 10a, a guidewire 32 has been advanced through the guide catheter 30a and through the space between the moveable member 54 and an adjacent wall of simulated anatomical structure. This may simulate advancement of the guidewire through a particular anatomical passage, such as a constricted ostium of a paranasal sinus. Also in FIG. 4A, the balloon catheter 50 has been advanced through the guide catheter 30a and over the guidewire 32 to a position where the deflated balloon 52 is positioned between the moveable member 54 and an adjacent wall of simulated anatomical structure, thereby simulating placement of the balloon 52 at the intended position (e.g., within a constricted ostium of a paranasal sinus).
In FIG. 4B, the balloon 52 is inflated, causing the moveable member 54 to move to a second position, as shown. Such movement of the optional moveable member 54 indicates that the balloon 52 has preformed its intended function (e.g., dilation of the constricted ostium of a paranasal sinus). As those of skill in the art will recognize, various other indicator members or indicator materials may be incorporated into the apparatus of the present invention to indicate when a particular device has or has not been correctly positioned or used.
FIG. 5 shows another embodiment of the apparatus 10b that may be of the same basic construction as the embodiment shown in FIGS. 1-3, but which includes an optional simulated anatomical opening 56 in the top panel 34a. In the showing of FIG. 5, a curved guide catheter 32a has been inserted through such optional opening 56. Those of skill in the art will appreciate that various opening may be formed at various locations in any of the apparatus 10, 10a, 10b of the present invention to simulate the actual locations of natural or man made body openings. Also, in some embodiments, ports or openings may be formed in the top panel 34, bottom panel 36 or elsewhere to allow substances or materials to be deposited in the simulated anatomical passageways to mimic the present of certain substances (e.g., body fluids, mucous, blood, puss) or pathological or anomalous conditions (e.g., polyps, tumors, fungus, mucoceles, etc.), thereby enhancing the use of the apparatus 10, 10a, 10b for training in the use of devices such as suction apparatus, irrigators, cutters, debriders, diagnostic catheters, etc.
It is to be further appreciated that, to add an increased sense or realism or three dimensional effect, the top panel 34 may be translucent or semi-opaque (with or without transparent areas) to simulate the effects of light emitting devices such as transilluminating lightwires or endoscopes and, thus, such apparatus may be used for training in the use of such light emitting devices.
In some embodiments, the apparatus 10, 10a, 10b of this invention may be endowed with more depth or three dimensional characteristics (e.g., like an actual human head or actual body part) to simulate actual insertion, manipulation and use of a scope and/or other devices. Any portions of the apparatus 10, 10a, 10b may be clear or opaque so that one may visualize via an inserted scope and/or through the sides of the apparatus (or not).
It is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless otherwise specified of if to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or process have been described or listed in a particular order, the order of such steps may be changed unless otherwise specified or unless doing so would render the method or process unworkable for its intended purpose. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.

## Claims

1. An apparatus useable for simulated insertion and positioning of a medical or surgical device within an anatomical opening or passageway that leads to a paranasal sinus, said apparatus comprising:
a substantially flat first panel having a top surface, a bottom surface and at least one side surface;
a simulated nasal opening formed in a side surface of the first panel;
a simulated nasal passage with a simulated intranasal septum on one side thereof;
at least one simulated paranasal sinus cavity;
at least one ostium or tract connecting the simulated nasal passage to said at least one simulated paranasal sinus cavity; and
a substantially flat second panel mounted in juxtaposition to the top surface of the flat first panel, said second panel comprising a window through which an operator may view the medical or surgical device as it is inserted through the simulated nasal opening and advanced through the simulated nasal passage to a position within said at least one ostium or tract or said at least one simulated paranasal sinus cavity; and
a substantially flat third panel mounted in juxtaposition to the bottom surface of the flat first panel;
wherein the simulated nasal passage and at least one simulated paranasal sinus cavity are substantially two-dimensional simulations of anatomical structures that naturally occur in three dimensions in the actual human paranasal anatomy.

2. An apparatus according to claim 1 wherein a plurality of simulated nasal openings are formed in one or more side surfaces of the panel.

3. An apparatus according to claim 1 further comprising one or more additional, substantially two-dimensional, simulated anatomical structures selected from projections, organs, bones, nasal turbinates and ucinate processes.

4. A method for simulated insertion and positioning of a medical or surgical device using an apparatus according to claim 1, said method comprising the steps of:
A) inserting a medical or surgical device through the simulated nasal opening; and
B) advancing the medical or surgical device through the through the substantially two-dimensional simulated nasal passage to a position within said at least one ostium or tract or said at least one substantially two-dimensional simulated paranasal sinus cavity while observing the advancement of the device through said window.

5. A method according to claim 4 wherein the medical or surgical device comprises a guide.

6. A method according to claim 4 wherein the medical or surgical device comprises a guidewire.

7. A method according to claim 4 wherein the medical or surgical device comprises a guide and a guidewire.

8. A method according to claim 5 further comprising the step of advancing a working device through the guide.

9. A method according to claim 6 further comprising the step of advancing a working device over the guidewire.

10. A method according to claim 7 further comprising the step of advancing a working device over the guidewire and through the guide.

11. A method according to claim 8 wherein the working device is selected from the group consisting of: dilation catheters, balloon catheters, cutting devices, atherectomy devices, implantable devices, implantable substance delivery devices, scopes, energy delivering devices, injection devices, sensors, and electrodes.

12. A method according to claim 4 wherein the operator observes advancement of a guide wire into a simulated paranasal sinus cavity and subsequent advancement of a working device over the guidewire to a position within a simulated ostium or tract that leads into that simulated paranasal sinus cavity.

13. A method according to claim 11 wherein the window comprises a transparent second panel placed in substantial juxtaposition to a top side of the first panel and wherein the operator observes the advancement or positioning of the medical or surgical device through that transparent second panel.